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Tumor Lysate Pulsed Dendritic Cell Immunotherapy for Patients With Brain Tumors

Primary Purpose

Glioblastoma

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Dendritic Cell Immunotherapy

About this trial

This is an interventional treatment trial for Glioblastoma focused on measuring New/Recurrent Glioblastoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

No age or gender limit, though minimal weight limitations for apheresis is about 15 - 20 Kg.
Both male and female of childbearing age entering the protocol must use a medically accepted form of birth control during the study, will be required to have a negative pregnancy test for female.
patients with atypical malignant brain tumor will be eligible.
Patients must have a Karnofsky performance score of at least 60%
patients may be maintained on glucocorticoid therapy at the lowest possible dose.
Baseline hematologic studies and chemistry profiles must meet the criteria.
Tumor specimen of adequate size to yield protein concentration in sufficient quantity.
Tumor-lysate peptide must be generated in sufficient quantity to pulse the APC's for vaccination.
Patient must have no prior sensitivity to the components of the dendritic cell vaccine.
Patient must agree to consider an autopsy in the event of death in an attempt to learn more concerning the nature of this treatment and tumor biology.
Patient must be capable of signing IRB approved Research Consent and Release of medical Records form.

Exclusion Criteria:

Severe pulmonary, cardiac or other systemic disease associated with an unacceptable anesthetic or operative risk.
The presence of an acute infection requiring active treatment will be criteria for delay or exclusion.
Patients with a known history of an autoimmune disorder.
Inability to give informed consent.
Pregnancy.

Sites / Locations

Cedars Sinai Medical center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dendritic Cell Immunotherapy

Arm Description

Patients who consent to participate in the study and receive the Dendritic Cell vaccine manufactured from their own tumor cells.

Outcomes

Primary Outcome Measures

Evaluate the safety/toxicity of subcutaneous injections of autologous dendritic cells

Cytotoxic T lymphocyte (CTL) precursor frequency

Secondary Outcome Measures

Full Information

NCT ID

NCT00576537

First Posted

December 18, 2007

Last Updated

April 30, 2019

Sponsor

Cedars-Sinai Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00576537

Brief Title

Tumor Lysate Pulsed Dendritic Cell Immunotherapy for Patients With Brain Tumors

Official Title

Phase ll Trial of Tumor Lysate-Pulsed Dendritic Cell Immunotherapy for Patients With Atypical or Malignant, Primary or Metastatic Brain Tumors of the Central Nervous System

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

March 2001 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cedars-Sinai Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This research is being determine whether vaccinations with your own immune cells called " dendritic cells " can activate your immune system to fight your brain tumor.

Detailed Description

To become eligible for therapy the following criteria must be fulfilled: No age or gender limit Patients with atypical malignant brain tumors. Must have a Karnofsky performance of at least 60% Hematologic studies and chemistry profiles will be within the parameters of the protocol Tumor specimen of adequate size to yield protein concentration, tumor lysate peptide must be generated in sufficient quantity and patient must have no prior sensitivity to the components of the dendritic cell vaccine. Patients are excluded if they have systemic disease, presence of acute infection, known history of autoimmune disorder and pregnancy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma

Keywords

New/Recurrent Glioblastoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dendritic Cell Immunotherapy

Arm Type

Experimental

Arm Description

Patients who consent to participate in the study and receive the Dendritic Cell vaccine manufactured from their own tumor cells.

Intervention Type

Biological

Intervention Name(s)

Dendritic Cell Immunotherapy

Other Intervention Name(s)

Dendritic Cell vaccine

Intervention Description

Patients will receive four vaccines.

Primary Outcome Measure Information:

Title

Evaluate the safety/toxicity of subcutaneous injections of autologous dendritic cells

Description

Cytotoxic T lymphocyte (CTL) precursor frequency

Time Frame

One year

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: No age or gender limit, though minimal weight limitations for apheresis is about 15 - 20 Kg. Both male and female of childbearing age entering the protocol must use a medically accepted form of birth control during the study, will be required to have a negative pregnancy test for female. patients with atypical malignant brain tumor will be eligible. Patients must have a Karnofsky performance score of at least 60% patients may be maintained on glucocorticoid therapy at the lowest possible dose. Baseline hematologic studies and chemistry profiles must meet the criteria. Tumor specimen of adequate size to yield protein concentration in sufficient quantity. Tumor-lysate peptide must be generated in sufficient quantity to pulse the APC's for vaccination. Patient must have no prior sensitivity to the components of the dendritic cell vaccine. Patient must agree to consider an autopsy in the event of death in an attempt to learn more concerning the nature of this treatment and tumor biology. Patient must be capable of signing IRB approved Research Consent and Release of medical Records form. Exclusion Criteria: Severe pulmonary, cardiac or other systemic disease associated with an unacceptable anesthetic or operative risk. The presence of an acute infection requiring active treatment will be criteria for delay or exclusion. Patients with a known history of an autoimmune disorder. Inability to give informed consent. Pregnancy.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Yu, M.D.

Organizational Affiliation

Cedars-Sinai Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cedars Sinai Medical center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

24893855

Citation

Jouanneau E, Black KL, Veiga L, Cordner R, Goverdhana S, Zhai Y, Zhang XX, Panwar A, Mardiros A, Wang H, Gragg A, Zandian M, Irvin DK, Wheeler CJ. Intrinsically de-sialylated CD103(+) CD8 T cells mediate beneficial anti-glioma immune responses. Cancer Immunol Immunother. 2014 Sep;63(9):911-24. doi: 10.1007/s00262-014-1559-2. Epub 2014 Jun 4.

Results Reference

derived

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Tumor Lysate Pulsed Dendritic Cell Immunotherapy for Patients With Brain Tumors

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